Clinical trial · Interventional
Integrated Positron Emission Tomography Magnetic Resonance (PET/MR) of Breast Cancer
Use of Integrated PET/MR to Evaluate Clinical Staging and Monitor Treatment Response of Neoadjuvant Chemotherapy for Breast Cancer Patients: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators will use integrated PET/MR for the goals below: 1. Use of PET-guided proton MRS (MR spectroscopy) and DCE MRI (dynamic contrast-enhanced MRI) for patients who will receive NAC (neoadjuvant chemotherapy) for breast cancer to monitor treatment response. 2. Use of dynamic and static PET to monitor treatment response for NAC, and to investigate the correlation of PET results versus MRS, DCE MRI. 3. Compare clinical staging by PET/MR and by clinical assessment. 4. On pre-chemotherapy studies, to investigate the association of molecular marker status with the dynamic and static PET, MRS and DCE MRI parameters.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PETMR study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PETMR study
- description
- All the study participants will receive PET MR examinations before neoadjuvant chemotherapy and during neoadjuvant chemotherapy (during early cycle as well as during mid-cycle of chemotherapy treatment). There will be two groups of patients after completion of neoadjuvant chemotherapy, that is, responders versus non-responders. We will compare the PET MR imaging parameters before, during neoadjuvant chemotherapy between the two groups of patients.
- interventionNames
- Other: PETMR study
Primary outcomes (1)
- measure
- treatment effect of neoadjuvant chemotherapy evaluated by positron emission tomography magnetic resonance (PET/MR)
- timeFrame
- 7 months for each patient
Secondary outcomes (1)
- measure
- Clinical staging of pre-chemotherapy breast cancer by PET/MR
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged 25-75 years old. 2. Women with recently diagnosed breast cancer and who will receive NAC to reduce tumor burden before surgery. (including locally advanced breast cancer (LABC) according to clinical assessment; or tumor size \> 2cm, that is, at least T2 in TNM staging). Exclusion Criteria: 1. Estimated GFR (eGFR) \< 60 mL/min/1.73 m2 and blood glucose \> 135 mg/dl; Past or present history of acute renal failure, renal dialysis, diabetes mellitus. 2. Women who received metallic fixation, coronary artery stent in recent 3 months; or women who received mechanical valve replacement that is not compatible with MR magnet; or women with aneurysmal clips, pacemakers. 3. Past history of claustrophobia. 4. Women who are pregnant or who are planning to be pregnant, or who are lactating (though the possibility in our target population should be very low) 5. Past history of breast cancer within recent 5 years before the currently diagnosed breast cancer. 6. Women who received chemotherapy for other disease entity in recent 1 year. 7. Women who cannot cooperate with the examinations.
References
Publications (0)
Data not yet available